scholarly journals Gemcitabine for the treatment of metastatic breast cancer

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 1-7
Author(s):  
J Jones ◽  
A Takeda ◽  
SC Tan ◽  
K Cooper ◽  
E Loveman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Indirect Comparison ◽  
Metastatic Breast ◽  
Base Case ◽  
Health State ◽  
Single Technology Appraisal ◽  
Quality Adjusted Life

This paper presents a summary of the evidence review group (ERG) report into the evidence for the clinical effectiveness and cost-effectiveness of gemcitabine with paclitaxel for the first-line treatment of metastatic breast cancer (MBC) in patients who have already received chemotherapy treatment with an anthracycline, compared with current standard of care, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence for gemcitabine as a treatment for MBC comes from the unpublished JHQG trial (some data commercial-in-confidence): overall survival was 3 months longer for the gemcitabine/paclitaxel arm (18.5 months) than for the paclitaxel arm (15.8 months) (p = 0.0489); gemcitabine/paclitaxel also improved tumour response and time to documented progression of disease compared with paclitaxel monotherapy, but haematological serious adverse events were more common. In the absence of any formal methods of indirect comparison there is insufficient robust evidence to compare the relative effectiveness of gemcitabine/paclitaxel with docetaxel monotherapy or docetaxel/capecitabine combination therapy. The manufacturers used a Markov state transition model to estimate the effect of treatment with five different chemotherapy regimes, adopting a 3-year time horizon with docetaxel monotherapy as the comparator. Health state utilities for different stages of disease progression and for patients experiencing treatment-related toxicity are used to derive quality-adjusted life expectancy with each treatment. The base-case cost-effectiveness estimate for gemcitabine/paclitaxel versus docetaxel is £17,168 per quality-adjusted life-year (QALY). When longer survival with docetaxel is assumed in a sensitivity analysis, the incremental cost-effectiveness ratio (ICER) is £30,000 per QALY. Probabilistic sensitivity analysis estimates a 70% probability of gemcitabine/paclitaxel being cost-effective relative to docetaxel at a willingness-to-pay threshold of £35,000. There is considerable uncertainty over the results because of the lack of formal quality assessment or assessment of the comparability of the 15 trials included in the input data, and the questionable validity of the indirect comparison method adopted. An illustrative analysis using a different method for indirect comparison carried out by the ERG produces an ICER of £45,811 per QALY for gemcitabine/paclitaxel versus docetaxel. The guidance issued by NICE in November 2006 as a result of the STA states that gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an option for the treatment of MBC only when docetaxel monotherapy or docetaxel plus capecitabine is also considered appropriate.

scholarly journals Infliximab for the treatment of adults with psoriasis

2009 ◽  
Vol 13 (Suppl 1) ◽  
pp. 55-60
Author(s):  
E Loveman ◽  
D Turner ◽  
D Hartwell ◽  
K Cooper ◽  
A Clegg
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Plaque Psoriasis ◽  
Indirect Comparison ◽  
Response To Treatment ◽  
Base Case ◽  
Infliximab Treatment ◽  
Single Technology Appraisal ◽  
Severe Plaque Psoriasis ◽  
Pasi Score

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of infliximab for the treatment of moderate to severe plaque psoriasis, in accordance with the licensed indication, based on the evidence submission from Schering-Plough to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer’s definition of the decision problem were severity [Psoriasis Area and Severity Index (PASI) score], remission rates, relapse rates and health-related quality of life. The main evidence in the submission comes from four randomised controlled trials (RCT) comparing infliximab with placebo and eight RCTs comparing either etanercept or efalizumab with placebo. At week 10, patients on infliximab had a significantly higher likelihood of attaining a reduction in PASI score than placebo patients. There were also statistically significant differences between infliximab and placebo in the secondary outcomes. In the comparator trials both the efalizumab and etanercept arms included a significantly higher proportion of patients who achieved a reduction in PASI score at week 12 than the placebo arms. No head-to-head studies were identified directly comparing infliximab with etanercept or efalizumab. The manufacturer carried out an indirect comparison, but the ERG had reservations about the comparison because of the lack of information presented and areas of uncertainty in relation to the included data. The economic model presented by the manufacturer was appropriate for the disease area and given the available data. The cost-effectiveness analysis estimates the mean length of time that an individual would respond to infliximab compared with continuous etanercept and the utility gains associated with this response. The base-case incremental cost-effectiveness ratio (ICER) for infliximab compared with continuous etanercept for patients with severe psoriasis was £26,095 per quality-adjusted life-year. A one-way sensitivity analysis, a scenario analysis and a probabilistic sensitivity analysis were undertaken by the ERG. The ICER is highly sensitive to assumptions about the costs and frequency of inpatient stays for non-responders of infliximab. The guidance issued by NICE in August 2007 as a result of the STA states that infliximab within its licensed indication is recommended for the treatment of adults with very severe plaque psoriasis, or with psoriasis that has failed to respond to standard systematic therapies. Infliximab treatment should be continued beyond 10 weeks in people whose psoriasis has shown an adequate response to treatment within 10 weeks. In addition, when using the Dermatology Life Quality Index (DLQI), care should be taken to take into account the patient’s disabilities, to ensure DLQI continues to be an accurate measure.

The quality-of-life impact of osteonecrosis of the jaw: Implications for bisphosphonate use in metastatic breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6620-6620
Author(s):  
R. A. Miksad ◽  
S. Come ◽  
M. Weinstein
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Decision Analysis ◽  
Metastatic Breast ◽  
Osteonecrosis Of The Jaw ◽  
Base Case ◽  
Treat All ◽  
Quality Adjusted Life

6620 Background: Osteonecrosis of the jaw (ONJ) has been linked to bisphosphonates used to prevent skeletal related events (SREs) in metastatic breast cancer (MBC). The primary aim of this decision-analysis study is to determine the preference threshold at which the quality of life (QOL) impact of ONJ may change bisphosphonate treatment decisions. Methods: We developed a Markov decision- analysis model of bisphosphonate use in MBC that includes the risk of ONJ. For the base case we estimated the QOL impact of ONJ by evaluating published ONJ reports with the Oral Health Impact Profile (OHIP). OHIP scores were transformed to EQ5D utilities and adjusted for MBC (published utility for MBC=0.63). We used published utility values for SRE: 0.46 for the month in which SRE occurs. Based on published data, we estimated that bisphosphonates reduce the incidence of SREs by 41% and that the incidence of SRE rises with increased bisphosphonate exposure: year 1=0.004/month; year 2=0.022/month; year 3=0.034/month. We inspected 2 treatment strategies: treat all patients with bisphosphonates (treat all) and treat no patient with bisphosphonates (treat none). Results: 18 published cases were adequate for evaluation. The mean OHIP score=27 (possible range 14–70), s.d.=1.8. We calculated that patients with MBC and ONJ have a utility=0.53 (s.d.=0.04) for the base-case. The model predicted a mean survival of 22 months for both strategies. In the treat all strategy each patient received a mean of 19 months of bisphosphonates and suffered 2.4 SREs. In the treat none strategy each patient suffered 4.0 SREs. In the base case, the treat all strategy maximized net quality-adjusted life, although by less than 1/2 month per patient. The treat all strategy was optimal for only 33% of patients. The treat all strategy does not maximize net quality-adjusted life if the risk of ONJ is 4.5 times higher than the base case or the ratio of the utility for ONJ to the utility for SRE is less than 0.4 (base-case ratio=1.152). Conclusions: The QOL impact of ONJ alters the decision to use bisphosphonates when 1) the incidence of ONJ is 4.5 times higher than published estimates; or 2) the long-term preference for ONJ is 60% lower than the short-term preference for SRE. Further QOL research may refine these estimates. No significant financial relationships to disclose.

scholarly journals Cost-Effectiveness of Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer

2016 ◽  
Vol 34 (9) ◽  
pp. 902-909 ◽  
Author(s):  
Ben Y. Durkee ◽  
Yushen Qian ◽  
Erqi L. Pollom ◽  
Martin T. King ◽  
Sara A. Dudley ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Epidermal Growth Factor Receptor ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Cost Effective ◽  
Life Years ◽  
Epidermal Growth

Purpose The Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study showed a 15.7-month survival benefit with the addition of pertuzumab to docetaxel and trastuzumab (THP) as first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) –overexpressing metastatic breast cancer. We performed a cost-effectiveness analysis to assess the value of adding pertuzumab. Patient and Methods We developed a decision-analytic Markov model to evaluate the cost effectiveness of docetaxel plus trastuzumab (TH) with or without pertuzumab in US patients with metastatic breast cancer. The model followed patients weekly over their remaining lifetimes. Health states included stable disease, progressing disease, hospice, and death. Transition probabilities were based on the CLEOPATRA study. Costs reflected the 2014 Medicare rates. Health state utilities were the same as those used in other recent cost-effectiveness studies of trastuzumab and pertuzumab. Outcomes included health benefits expressed as discounted quality-adjusted life-years (QALYs), costs in US dollars, and cost effectiveness expressed as an incremental cost-effectiveness ratio. One- and multiway deterministic and probabilistic sensitivity analyses explored the effects of specific assumptions. Results Modeled median survival was 39.4 months for TH and 56.9 months for THP. The addition of pertuzumab resulted in an additional 1.81 life-years gained, or 0.62 QALYs, at a cost of $472,668 per QALY gained. Deterministic sensitivity analysis showed that THP is unlikely to be cost effective even under the most favorable assumptions, and probabilistic sensitivity analysis predicted 0% chance of cost effectiveness at a willingness to pay of $100,000 per QALY gained. Conclusion THP in patients with metastatic HER2-positive breast cancer is unlikely to be cost effective in the United States.

scholarly journals Cost-Effectiveness Analysis of Abemaciclib Plus Fulvestrant in the Second-Line Treatment of Women With HR+/HER2– Advanced or Metastatic Breast Cancer: A US Payer Perspective

2021 ◽  
Vol 8 ◽  
Author(s):  
Yingcheng Wang ◽  
Mingjun Rui ◽  
Xin Guan ◽  
Yingdan Cao ◽  
Pingyu Chen
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Metastatic Breast ◽  
Cost Effective ◽  
Additional Cost ◽  
Line Treatment ◽  
Second Line ◽  
The Us

Introduction: This study evaluated the cost-effectiveness of abemaciclib plus fulvestrant (ABE + FUL) vs. palbociclib plus fulvestrant (PAL + FUL), ribociclib plus fulvestrant (RIB + FUL) and fulvestrant monotherapy (FUL) as second-line treatment for hormone receptor-positive and human epidermal growth factor receptor 2- negative advanced or metastatic breast cancer in the US.Methods: The 3 health states partitioned survival (PS) model was used over the lifetime. Effectiveness and safety data were derived from the MONARCH 2 trial, MONALEESA-3 trial, and PALOMA-3 trial. Parametric survival models were used for four treatments to explore the long-term effect. Costs were derived from the pricing files of Medicare and Medicaid Services, and utility values were derived from published studies. Sensitivity analyses including one-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis were performed to observe model stability.Results: In the PS model, compared with PAL + FUL, ABE + FUL yielded 0.44 additional QALYs at an additional cost of $100,696 for an incremental cost-utility ratio (ICUR) of $229,039/QALY. Compared with RIB + FUL, ABE + FUL yielded 0.03 additional QALYs at an additional cost of $518 for an ICUR of $19,314/QALY. Compared with FUL, ABE + FUL yielded 0.68 additional QALYs at an additional cost of $260,584 for ICUR of $381,450/QALY. From the PS model, the ICUR was $270,576 /QALY (ABE + FUL vs. PAL + FUL), dominated (ABE + FUL vs. RIB + FUL) and $404,493/QALY (ABE + FUL vs. FUL) in scenario analysis. In the probabilistic sensitivity analysis, the probabilities that ABE + FUL was cost-effective vs. PAL + FUL, RIB + FUL and FUL at thresholds of $50,000, $100,000, and $200,000 per QALY gained were 0% and the probabilities that ABE + FUL was cost-effective vs. PAL + FUL and RIB + FUL at thresholds of $50,000, $100,000, and $200,000 per QALY gained were 0.2, 0.6, and 7.3%.Conclusions: The findings from the present analysis suggest that ABE + FUL might be cost-effective compared with RIB + FUL and not cost-effective compared with PAL + FUL and FUL for second-line treatment of patients with HR+/HER2– advanced or metastatic breast cancer in the US.

Survival and cost-effectiveness of docetaxel (D) and paclitaxel (P) in patients with metastatic breast cancer (MBC): A population-based evaluation

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6117-6117
Author(s):  
T. T. Vu ◽  
S. Ellard ◽  
I. Olivotto ◽  
S. C. Taylor ◽  
M. L. De Lemos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Single Agent ◽  
Metastatic Breast ◽  
Population Based ◽  
List Price ◽  
Rank Test ◽  
Eligibility Criteria

6117 Background: A randomized comparison between P and D for MBC reported that overall survival (OS) was significantly superior for D (Ravdin, et al). We report a population-based comparison of P (3-hour infusion) to D (1-hour infusion) in MBC patients with prior exposure to anthracycline in terms of OS and cost-effectiveness (CE). Methods: Data on MBC patients treated with single-agent P or D (January 1999 - December 2002) were retrospectively reviewed. OS, defined as time from initiation of taxane to death from any cause, was compared using a 2-tailed log-rank test and expressed as Kaplan-Meier plots. A CE analysis, including cost of drug (list price $CDN), labour and supplies, was performed using median cost/patient and median OS (MOS). Incremental CE ratios (ICERs) were compared in a sensitivity analysis varying MOS to the extremes of the 95% confidence interval (95% CI). Results: 435 patients met eligibility criteria. MBC prognostic factors were balanced between D and P groups ( table ). MOS was significantly longer for D vs. P. (10.9 vs. 8.3 months; HR 0.76; 95% CI, 0.62 to 0.92; P = 0.006). The median number of cycles administered were 4 (D) and 3 (P). The respective cost/month of MOS is $805 (D) and $303 (P). The ICER of D vs. P was $2,434/month MOS gained. The range of ICERs in the sensitivity analysis was $1,121 to 7,361/month MOS gained. These results were robust except that P dominates when the low end of the 95%CI of MOS for D is compared to the high end for P. Conclusion: This population-based study corroborates the randomized trial’s conclusion that for patients with metastatic breast cancer, D provided superior survival compared to P. Each additional month of survival had an incremental cost of $2,434. [Table: see text] [Table: see text]

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